Cognitive and Emotional Factors Relation to Treatment Adherence in Asthmatic Patients in Upper Egypt

Non-adherence to controller therapy is one of the main reasons of poor asthma control. Adherence to medication in different studies range between 30 and 70% . Several factors related to the disease, to the patient, treatment or physician- patient relationship

Study Overview

• Status: Not yet recruiting
• Conditions: Adherence, Medication; Bronchial Asthma

Detailed Description

Non-adherence to controller therapy is one of the main reasons for poor asthma control. Adherence to medication in different studies ranges between 30 and 70%. Several factors related to the disease, to the patient, treatment, or physician-patient relationship have been identified to be related to adherence in asthma and other diseases. According to the self-regulation theory, medication beliefs and illness perception are associated with treatment adherence. Beliefs about illness, the necessity, and the concerns (addition and side effects) of the treatment have been identified as the two most important elements in the proposed theory. Other factors that impact treatment adherence are the perceived efficacy of medicines, cost of therapy, complex dosing regimens, Patient's level of education, and cultural beliefs. Evaluating the beliefs about asthma medication, and cognitive and emotional perceptions may help to identify patients with poor adherence to treatment in clinical practice. That would guide additional attention helping to increase the likelihood of taking asthma medication appropriately. However, only limited information is available on treatment adherence in Egyptian people especially in upper Egypt. Furthermore, evidence identifying medication beliefs, and cognitive or emotional factors associated with asthma medication adherence among Egyptian people in upper Egypt is currently not available

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Nermen M Abuelkassem, lecturer; Phone Number: 01000767713; Email: Nermenabuelkassem@gmail.com
• Study Contact Backup: Name: Entsar H Mohamed, lecturer; Phone Number: +201019968106; Email: entsar.hsanen@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

138 asthmatic patients presented to respiratory outpatient clinic

Description

Inclusion Criteria:

1. Able to understand and provide informed consent.
2. Age ≥18y at the time of study enrollment.
3. Provider diagnosed asthma and prescribed maintenance ICS treatment and as needed bronchodilator for at least one month

Exclusion Criteria:

1. Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
2. Severe psychopathology (e.g., schizophrenia)
3. Apparent cognitive or language deficit
4. Patients with associated other chronic chest diseases

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Asthmatic patients presented to respiratory outpatient clinic; All subjects will be subjected to Complete history taking including demographic data, residence, educational level, income level, and presence of first- or second-degree medical relative. The first onset age of asthma and duration of asthma will be recorded. Factors that can affect treatment adherence are collected as type and number of medications, cost, inclusion in the health insurance system, availability, asthma-related comorbidities, and choice of drug and device. : To assess adherence we will use the Morisky Medication Adherence Scale (MMAS-8) as discussed above To assess patient beliefs, we will use The Beliefs about Medicines Questionnaire as discussed above To obtain information on illness perception we will use The Brief Illness Perception Questionnaire (Brief IPQ) as discussed above To assess asthma control we will use the asthma control test as discussed above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment adherence in asthmatic patients in upper Egypt and association to disease beliefs	simple questionnaires will be used to assess adherence, beliefs, and perception	one year

Collaborators and Investigators

• Sponsor: Entsar Hsanen
• Investigators: Principal Investigator: Entsar H Mohamed, Lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Cognitive and emotional factor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No